K132284 is an FDA 510(k) clearance for the VECTRA NEO CLINICAL THERAPY SYSTEM. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Djo, LLC (Vista, US). The FDA issued a Cleared decision on April 10, 2014, 261 days after receiving the submission on July 23, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K132284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2013 |
| Decision Date | April 10, 2014 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |